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A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec

Trial Profile

A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Dec 2024

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At a glance

  • Drugs Insulin lispro (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms OPTI-2
  • Sponsors Diasome Pharmaceuticals

Most Recent Events

  • 15 Jul 2024 Planned End Date changed from 1 Mar 2026 to 1 Dec 2025.
  • 15 Jul 2024 Planned primary completion date changed from 1 Dec 2025 to 1 Jun 2025.
  • 20 Mar 2024 According to a Diasome Pharmaceuticals media release, the company that the first participant has been dosed, and recruitment is ongoing, with the target completion date set for Q3 2025.

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